País: Estats Units
Idioma: anglès
Font: NLM (National Library of Medicine)
Ticlopidine hydrochloride (UNII: A1L4914FMF) (ticlopidine - UNII:OM90ZUW7M1)
Apotex Corp.
Ticlopidine hydrochloride
Ticlopidine hydrochloride 250 mg
PRESCRIPTION DRUG
Abbreviated New Drug Application
TICLOPIDINE HYDROCHLORIDE- TICLOPIDINE HYDROCHLORIDE TABLET, FILM COATED APOTEX CORP. ---------- TICLOPIDINE HYDROCHLORIDE TABLETS, USP 250 MG RX ONLY WARNING: TICLOPIDINE CAN CAUSE LIFE-THREATENING HEMATOLOGICAL ADVERSE REACTIONS, INCLUDING NEUTROPENIA/AGRANULOCYTOSIS, THROMBOTIC THROMBOCYTOPENIC PURPURA (TTP) AND APLASTIC ANEMIA. _NEUTROPENIA/AGRANULOCYTOSIS:_ AMONG 2048 PATIENTS IN CLINICAL TRIALS IN STROKE PATIENTS, THERE WERE 50 CASES (2.4%) OF NEUTROPENIA (LESS THAN 1200 NEUTROPHILS/MM ), AND THE NEUTROPHIL COUNT WAS BELOW 450/MM IN 17 OF THESE PATIENTS (0.8% OF THE TOTAL POPULATION). _TTP:_ ONE CASE OF THROMBOTIC THROMBOCYTOPENIC PURPURA WAS REPORTED DURING CLINICAL TRIALS IN STROKE PATIENTS. BASED ON POSTMARKETING DATA, US PHYSICIANS REPORTED ABOUT 100 CASES BETWEEN 1992 AND 1997. BASED ON AN ESTIMATED PATIENT EXPOSURE OF 2 MILLION TO 4 MILLION, AND ASSUMING AN EVENT REPORTING RATE OF 10% (THE TRUE RATE IS NOT KNOWN), THE INCIDENCE OF TICLOPIDINE-ASSOCIATED TTP MAY BE AS HIGH AS ONE CASE IN EVERY 2000 TO 4000 PATIENTS EXPOS ED. _APLASTIC ANEMIA:_ APLASTIC ANEMIA WAS NOT SEEN DURING CLINICAL TRIALS IN STROKE PATIENTS, BUT US PHYSICIANS REPORTED ABOUT 50 CASES BETWEEN 1992 AND 1998. BASED ON AN ESTIMATED PATIENT EXPOSURE OF 2 MILLION TO 4 MILLION, AND ASSUMING AN EVENT REPORTING RATE OF 10% (THE TRUE RATE IS NOT KNOWN), THE INCIDENCE OF TICLOPIDINE-ASSOCIATED APLASTIC ANEMIA MAY BE AS HIGH AS ONE CASE IN EVERY 4000 TO 8000 PATIENTS EXPOSED. _MONITORING OF CLINICAL AND HEMATOLOGIC STATUS:_ SEVERE HEMATOLOGICAL ADVERSE REACTIONS MAY OCCUR WITHIN A FEW DAYS OF THE START OF THERAPY. THE INCIDENCE OF TTP PEAKS AFTER ABOUT 3 TO 4 WEEKS OF THERAPY AND NEUTROPENIA PEAKS AT APPROXIMATELY 4 TO 6 WEEKS. THE INCIDENCE OF APLASTIC ANEMIA PEAKS AFTER ABOUT 4 TO 8 WEEKS OF THERAPY. THE INCIDENCE OF THE HEMATOLOGIC ADVERSE REACTIONS DECLINES THEREAFTER. ONLY A FEW CASES OF NEUTROPENIA, TTP, OR APLASTIC ANEMIA HAVE ARISEN AFTER MORE THAN 3 MONTHS OF THERAPY. HEMATOLOGICAL ADVERSE REACTIONS CANNOT BE RELIABLY PREDICTED BY AN Llegiu el document complet